By Mike Dark, CANHR Staff Attorney
After a ten-month battle with the most serious public health crisis in the history of long term care in the U.S., the cavalry is finally arriving, in the form of vaccines that have already been given Emergency Use Authorization (EUA) by regulators. Still more vaccines await in the pipeline, perhaps for January or February.
While the speedy development of these vaccines is an historic accomplishment, plans for their distribution and administration in the long term care setting are already troubled by the kind of decentralized decision-making and misunderstanding of the needs of long term care residents that have hobbled the public health response to the pandemic to date. Addressing these hurdles will be essential to the safe and effective roll-out of these promising treatments to communities ravaged by the virus.
First, the good news: both vaccines have proven to be effective at preventing about 95% of symptomatic disease in the populations being studied in phase three trials, a remarkable benchmark rivaling the efficacy of the polio vaccine. Nevertheless, both drugs, one developed by Pfizer and the other by Moderna, still need considerable further study before their safety and side effect profiles are fully understood. Neither has been systematically tested in long term care settings such as nursing homes, and their ability to reduce the transmission of the virus is unknown.
Importantly, neither has been fully vetted through the usual three-phase process for approval by the Food and Drug Administration. Instead, manufacturers of both drugs sought approval through the EUA process, which allows for the immediate use of promising treatments even before full safety testing is completed in the final phase of drug trials, so long as benefits strongly outweigh potential harm.[1] Under the EUA process, safety testing will instead be completed while the drugs are made available to the public. The Pfizer drug received its emergency use approval December 11, while the Moderna vaccine was approved under these provisions December 17.
Because both vaccines are in only the early stages of production, and because demand for the drugs during the surging pandemic is so high, the next few months will see a drug rationing program unfold the likes of which has not been seen since World War II. To rationalize this process, the U.S. Centers for Disease Control sought the advice of a panel of scientists, the Advisory Committee on Immunization Practices. (ACIP), which was tasked with setting priorities for the distribution of vaccines over the next several months.[2]
After a transparent public process of weighing scientific, implementation, and ethical considerations, ACIP determined that top priority, termed 1A, should be given to healthcare workers and to residents of long term care facilities.[3] On December 20 ACIP voted to include “frontline essential workers” and people 75 years of age and older as next-in-line for eligibility under 1B Category, a group that would include about 49 million Americans. While category 1C has yet to be voted on, it is likely to encompass persons between the ages of 65 and 74, those between 16 and 64 who have high-risk underlying conditions and remaining essential workers.[4]
California engaged in a simultaneous review of these priorities by forming a Scientific Safety Review Workgroup[5] and a Community Vaccine Advisory Committee, consisting of stakeholder organizations representing a broad array of California communities, including CANHR. These groups quickly adopted the same definition of Category 1A to include residents of long term care facilities. These committees are now turning to the group to be included in priority categories 1A and 1B.
While the testing and prioritization of these new vaccines has been organized and logical, far less attention has been paid to how vaccines will actually make their way to residents of California’s nursing home and assisted living facilities, and how these residents will be able to exercise consent in choosing to receive a vaccine. Moreover, the window for planning this roll-out is vanishingly small.
To enable residents of long term care to participate meaningfully in decisions about vaccination, physicians have a responsibility to provide information and help patients understand the risks and benefits of this treatment. There are three areas that should be of special concern to long term care residents and their families.
First, many long term care residents do not even know the name of their physician, and their isolation over the last nine months as a result of visitation restrictions makes them unlikely to benefit from mass media efforts to educate the public regarding vaccines. A tailored campaign addressing the special needs of long term care residents is called for, perhaps including a short video in the appropriate language that can be shown to residents explaining the vaccines and their risks and benefits, with subtext for residents who are hearing-impaired. Such a video could usefully supplement, but not replace, a discussion with a physician.
Second, and relatedly, the support of family will be essential for residents weighing whether to consent to vaccination. Current restrictions on visitation posed by the state agencies and by county public health departments may make it difficult for family to provide this assistance. In addition, hearing and cognitive limitations and inconsistent availability of alternative means of contact such as Facetime underscore the importance that this support be provided in person. This problem could be addressed by the issuance of an All Facilities Letter by the California Department of Public Health and a Provider Information Notice by the Department of Social Services’ Community Care Licensing Division mandating that facilities permit a family member, with appropriate safety measures in place, to enter a facility to provide this support in the context of vaccination decision-making.
Thirdly, special concerns exist about efforts to obtain consent from residents with limited capacity. Close to two-thirds of all U.S. nursing home residents have some form of cognitive impairment such as Alzheimer’s disease.[6] While legal surrogates such as family members with power of attorney can make decisions for residents who are deemed to lack capacity, these formal arrangements are uncommon, and decision making is often left to informal arrangements not currently recognized by California law.[7] Safe and effective COVID-19 vaccination, while essential for the well-being of long term care residents, is an unusually controversial topic, even within families. Consequently, a clear statement of legal authority of family members to make such decisions for residents lacking capacity is an important safeguard both for residents and for family decisionmakers.
Finally, for all types of residents, whether or not they are deemed to have capacity, a standardized form with appropriate disclosures should be developed and employed across all types of facilities to document that appropriate efforts have been made to obtain the consent of residents.
Vastly complicating the adoption of such measures is the disorganized and decentralized decision making that has characterized the State’s approach to the pandemic thus far. The State asserts that only county departments of health have authority to execute on plans to vaccinate elders in facilities, and some counties, such as Los Angeles, have in turn left it to facilities themselves to coordinate and manage their own vaccine responses, an approach that has proved to be disastrous at every turn thus far in the pandemic.[8]
It will be critical in the next weeks for the State to take a much stronger oversight role in ensuring that facilities follow the law in obtaining consent to vaccinations, a necessary about-face to the largely laissez-faire approach regulators have taken to facility oversight during the pandemic thus far.
When we are so close to the end of this marathon, it is essential that state agencies not shirk their responsibilities to ensure that we all make it over the finish line together.